A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody-Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers

Trial ID # NCT03748186
Phase I
Drug Class Antibody Drug Conjugates: FRalpha
Drug Name STRO-002
Drugs in Trial STRO-002
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

39, median 6 prior therapies (2-11); 82% w/ prior bevacizumab

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

CBR, ORR, DCR, PFS, evaluated per RECIST

Efficacy

Results from dose escalation, doses 2.9 mg/kg and above:

ORR: 32% (1CR, 4PR, 5uPR, n=31)
DCR (4 months): 61%
CBR: 55%
DCR (1 year): 16%
PFS: 7.2 months

Clinically Significant Adverse Events

Serious AE: none
Grade 3-4 AE: neutropenia (56%), arthralgia (15%), fatigue (10%) - only 1 pt required therapeutic corticosteroid eyedrops

Conclusion

STRO-002 is well tolerated with evidence of anti-tumor activity in heavily pretreated patients

Reference

Naumann RW et al. Phase 1 dose-escalation study of STRO-002, an antifolate receptor alpha (FRα) antibody drug conjugate (ADC), in patients with advanced, progressive platinum-resistant/refractory epithelial ovarian cancer (EOC). J Clin Oncol (2021) 39 (suppl 15; abstr 5550)
https://meetinglibrary.asco.org/record/197364/abstract

Naumann RW et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2021/06/STRO-002-poster-ASCO-2021-scaled.jpeg

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